Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

NCT ID: NCT00426621

Last Updated: 2007-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-06-30

Brief Summary

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This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Detailed Description

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Conditions

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Osteoarthritis of the Knee

Keywords

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Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID, diclofenac sodium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Diclofenac Sodium Gel

Intervention Type DRUG

4 grams per knee, 4 times per day, for 12 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 grams per knee, 4 times per day, for 12 weeks

Interventions

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Diclofenac Sodium Gel

4 grams per knee, 4 times per day, for 12 weeks

Intervention Type DRUG

Placebo

4 grams per knee, 4 times per day, for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of the knee

Exclusion Criteria

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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University of California, in Los Angeles, Division of Rheumatology,

Principal Investigators

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Roy Altman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, in Los Angeles, Division of Rheumatology, 310 206 7866

Locations

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Coastal Clinical Research Inc

Mobile, Alabama, United States

Site Status

River Region Research, LLC

Tallassee, Alabama, United States

Site Status

East Valley Family Physicians

Chandler, Arizona, United States

Site Status

HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Heartland Research Associates LLC

Arkansas City, Arkansas, United States

Site Status

Lovelace Scientific Research, Inc.

Beverly Hills, California, United States

Site Status

MED Investigations

Carmichael, California, United States

Site Status

MED Investigations, Inc.

Fair Oaks, California, United States

Site Status

Universal BioPharma Research, Inc.

Fresno, California, United States

Site Status

Santa Barbara Clinical Research, Inc

Santa Barbara, California, United States

Site Status

Pacific Arthritis Center Medical Group

Santa Maria, California, United States

Site Status

Clinical Research Consultants, LLC

Stratford, Connecticut, United States

Site Status

Seidman Clinical Trials

Delray Beach, Florida, United States

Site Status

Florida Medical Research Institute

Gainesville, Florida, United States

Site Status

South Florida Clinical Research Center

Hollywood, Florida, United States

Site Status

Health Awareness, Inc.

Jupiter, Florida, United States

Site Status

Suncoast Internal Medicine Consultants

Largo, Florida, United States

Site Status

AppleMed Research, Inc.

Miami, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Sunshine Research Center, LLC

Opa-locka, Florida, United States

Site Status

Peninsula Research, Inc.

Ormond Beach, Florida, United States

Site Status

University Clinical Research, Inc.

Pembroke Pines, Florida, United States

Site Status

Andres Patron DO PA

Pembroke Pines, Florida, United States

Site Status

Radiant Research - St Petersburg

Pinellas Park, Florida, United States

Site Status

Sunrise Medical Research

Plantation, Florida, United States

Site Status

Coastal Medical Research

Port Orange, Florida, United States

Site Status

Radiant Research

Stuart, Florida, United States

Site Status

Intermountain Orthopaedics

Boise, Idaho, United States

Site Status

Medical Specialists Clinical Research Center

Munster, Indiana, United States

Site Status

Heartland Research Associates, LLC

Newton, Kansas, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Best Clinical Trial, LLC

New Orleans, Louisiana, United States

Site Status

Peter A. Holt, MD

Baltimore, Maryland, United States

Site Status

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

Site Status

Phase III Clinical Research

Fall River, Massachusetts, United States

Site Status

Professional Clinical Research, Inc

Cadillac, Michigan, United States

Site Status

Twin Cities Clinical Research

Brooklyn Center, Minnesota, United States

Site Status

The Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

St. Louis Center for Clinical Research

St Louis, Missouri, United States

Site Status

Internal Medical Associates

Grand Island, Nebraska, United States

Site Status

South Jersey Medical Associates, PA

Blackwood, New Jersey, United States

Site Status

North Carolina Arthritis & Allergy Care Center

Raleigh, North Carolina, United States

Site Status

Rapid Medical Research, Inc

Cleveland, Ohio, United States

Site Status

Radiant Research

Columbus, Ohio, United States

Site Status

Radiant Research, Inc. - Akron

Mogadore, Ohio, United States

Site Status

Clinical Research Source, Inc

Perrysburg, Ohio, United States

Site Status

Neshaminy Medical, PC

Bensalem, Pennsylvania, United States

Site Status

Westminster Family Medicine

Erie, Pennsylvania, United States

Site Status

Feasterville Family Health Care Center

Feasterville, Pennsylvania, United States

Site Status

Southeastern Pennsylvania Medical Institute

Havertown, Pennsylvania, United States

Site Status

Radiant Research

Philadelphia, Pennsylvania, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Radiant Research - Anderson

Anderson, South Carolina, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Site Status

Walter F. Chase, M.D., P.A.

Austin, Texas, United States

Site Status

Radiant Research Dallas North

Dallas, Texas, United States

Site Status

Quality Research, Inc.

San Antonio, Texas, United States

Site Status

Radiant Research - San Antonio

San Antonio, Texas, United States

Site Status

Texas Research Center, LLP

Sugar Land, Texas, United States

Site Status

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Site Status

Tidewater Integrated Medical Research

Virginia Beach, Virginia, United States

Site Status

The Physicians Clinic of Spokane

Spokane, Washington, United States

Site Status

Advanced Healthcare

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.

Reference Type DERIVED
PMID: 21174485 (View on PubMed)

Other Identifiers

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VOSG-PN-316

Identifier Type: -

Identifier Source: org_study_id